Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

NCT02951351 | Completed Results DMC

• 1 other identifier: 16-004063
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.

Conditions

Age-related Macular Degeneration; Diabetic Macular Edema; Injection Site; Injection Site Infection; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Number of Study Participants With Positive Conjunctival Culture

  Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.

  pre-injection

• Pain at the Time of Injection

  Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain.

  post-injection

Secondary Outcomes (6)

• Residual Pain From Intravitreal Injection

  post-injection

• Overall Impression of Visit for Intravitreal Injection

  post-injection

• Impression of Pre-injection Preparations

  post-injection

• Comfort With Intravitreal Injection Standard Procedure

  post-injection

• Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health

  post-injection

Study Arms (2)

Standard procedure + Culture

ACTIVE COMPARATOR

Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.

Procedure: Conjunctival culture

Proparacaine + Culture

EXPERIMENTAL

Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.

Drug: Proparacaine; Procedure: Conjunctival culture

Interventions

Proparacaine DRUG

Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.

Also known as: alcaine

Proparacaine + Culture

Conjunctival culture PROCEDURE

Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.

Proparacaine + Culture; Standard procedure + Culture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing intravitreal injection who do not have active eye infections
• greater than 18 years of age

You may not qualify if:

• patients younger than 18 years of age
• patients with active eye infections

Sponsors & Collaborators

• Mayo Clinic: lead
• VitreoRetinal Surgery, PA: collaborator
• Research to Prevent Blindness: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Publications (4)

• Isenberg SJ, Apt L, Yoshimori R, Khwarg S. Chemical preparation of the eye in ophthalmic surgery. IV. Comparison of povidone-iodine on the conjunctiva with a prophylactic antibiotic. Arch Ophthalmol. 1985 Sep;103(9):1340-2. doi: 10.1001/archopht.1985.01050090092039.

  PMID: 2994609 BACKGROUND

• Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.

  PMID: 6721765 BACKGROUND

• Oguz H, Oguz E, Karadede S, Aslan G. The antibacterial effect of topical anesthetic proparacaine on conjunctival flora. Int Ophthalmol. 1999;23(2):117-20. doi: 10.1023/a:1026567912389.

  PMID: 11196120 BACKGROUND

• van Asten F, van Middendorp H, Verkerk S, Breukink MB, Lomme RM, Hoyng CB, Evers AW, Klevering BJ. ARE INTRAVITREAL INJECTIONS WITH ULTRATHIN 33-G NEEDLES LESS PAINFUL THAN THE COMMONLY USED 30-G NEEDLES? Retina. 2015 Sep;35(9):1778-85. doi: 10.1097/IAE.0000000000000550.

  PMID: 25901838 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Macular Degeneration; Pain, Postoperative

Interventions

proxymetacaine

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Margaret M. Reynolds, MD
• Organization: Mayo Clinic

margaretmmreynolds@gmail.com

507-284-2733

Study Officials

• Jose S Pulido, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2016
• First Posted: November 1, 2016
• Study Start: October 12, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 12, 2023
• Results First Posted: June 25, 2019

Record last verified: 2023-04

Locations

US (1)